Devices, systems, and methods for training pelvic floor muscles
Inventors
Beer, Marc D. • Iglesias, Ramon Jose • LORIE, Yolanda
Assignees
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Publication Number
US-12220345-B2
Publication Date
2025-02-11
Expiration Date
Abstract
Featured are intravaginal devices and methods of using the devices to observe the state of an individual's pelvic floor muscles in order to diagnose, treat, or prevent pelvic floor disorders (e.g., pelvic organ prolapse and incontinence) and their accompanying symptoms and methods of using the devices to treat or prevent vaginal disorders (e.g., skin laxity) in a subject using an energy transmitter (e.g., a radiofrequency transmitter).
Core Innovation
The invention relates to an intravaginal device for pelvic floor muscle training and monitoring, using pelvic floor lifts/relaxations and sensor-based monitoring for pelvic floor disorders and vaginal conditions. The device includes a main body that encircles the cervix or vaginal cuff, and a tether that carries motion-detecting sensors positioned within a defined distance of the main body, with biofeedback based on the sensed motion.
A central aspect is the use of multiple accelerometers disposed along a length of the device, with each accelerometer separated by about 1.6 cm. The device determines pelvic floor angles, including a vaginal angle and a fornix angle, using reference geometry that includes a horizon and the positions of sensors along the device length.
Additional sensor capabilities are described, including selectable sensing options such as LiDAR, electrical impedance myography, MEMS sensor, gyroscope, G-sensor, tilt sensor, rotation sensor, light detecting sensor, and biological and chemical sensors including pressure, muscle quality, muscle strength, pH, humidity, temperature, hormone, and toxin sensors. The system also includes therapeutic energy delivery and control, optional communication with an electronic device via wired or wireless communication, and a graphical user interface for sensor-based measurements and biofeedback.
Claims Coverage
The provided claims coverage centers on an intravaginal device with multiple accelerometers disposed along the device length with a specified separation distance, together with dependent claim refinements for microcontroller electronics, selectable sensors, geometry-based angle definitions, communication, and a graphical user interface. Only one independent claim family is explicitly identified across the inputs, directed to the accelerometer-spaced intravaginal device.
Multiple accelerometers with defined spacing along device length
An intravaginal device comprising 2, 3, 4, 5, 6, 7, 9, or 10 accelerometers disposed along a length of the device, wherein each of the accelerometers are separated by a distance of about 1.6 cm.
Microcontroller-based sensing with external power and communication to an electronic device
An intravaginal device including a microcontroller with accelerometers, one or more communication transmitters and receivers for sending data to an electronic device via wired and optionally wireless links, an external-housing transmitter and receiver connected by a detachable cable, a power source for the accelerometers, and a defined vaginal angle based on positions of accelerometers relative to the horizon.
Geometric vaginal angle defined relative to a horizon
An intravaginal device that defines a vaginal angle based on a line drawn between the position of at least two accelerometers in the device tether and a horizon reference.
Vaginal-angle-based device length constraint
The intravaginal device further has a device length of about 25.5 cm.
Display and Bluetooth/Wi-Fi communication to selected electronic devices
The intravaginal device includes an electronic device with a display and Bluetooth and/or Wi-Fi transmitter and receiver that communicates data between the intravaginal device and an electronic device selected from a computer, tablet, smartphone, or smart watch.
Selectable additional sensor types beyond accelerometers
The intravaginal device includes a combination of sensors of different types, and may further include additional sensors selected from pressure, muscle quality, muscle strength, pH, humidity, temperature, hormone, and toxin sensors.
Graphical user interface for the intravaginal device system
A system that includes the intravaginal device together with a graphical user interface.
The claims cover an intravaginal device architecture that positions multiple accelerometers along the device length with a specified separation, and extends to microcontroller control, external power, wired or optional wireless communication, geometry-based vaginal angle definitions relative to a horizon, selectable sensor types, and a graphical user interface.
Stated Advantages
Biofeedback based on sensor monitoring is provided through a graphical user interface.
The system is directed to diagnosing and treating pelvic floor disorders, including pelvic organ prolapse and urinary incontinence, and vaginal laxity.
Documented Applications
Pelvic floor disorder applications including pelvic organ prolapse and urinary incontinence, including stress urinary incontinence and urge incontinence.
Vaginal laxity.
Diagnosis and treatment using monitoring during pelvic floor lift and pelvic floor relaxation maneuvers with angle and curvature thresholds.
Optional pharmaceutical or energy-based therapy configurations, including RF heating for collagen strengthening.
Intravaginal drug delivery using pharmaceutical agents with local and/or systemic release, including zero-order, sustained, and delayed release.
Live Mode monitoring.
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